NCT02067182

Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Georg Nickenig · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of OAC in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF (Camm JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful ablation in these patients remains to some extent un-clear. As OAC bears the risk of bleeding events, the ODIn-AF study aims to evalu-ate the positive effect of OAC on the incidence of silent cerebral embolic events in patients with a high risk for embolic events, free from AF after successful pulmo-nary vein ablation. ODIn-AF aims to determine that continued administration of dabigatran is superior in the preven-tion of silent cerebral embolism to discontinuation of OAC after 3 months in pa-tients free from symptomatic AF-episodes with a CHA2DS2VASc score ≥2 after the first pulmonary vein ablation for paroxysmal AF.

Conditions

• Atrial Fibrillation
• Cardioembolic Events
• Oral Anticoagulation

Interventions

Type	Name	Description
DRUG	Dabigatran	* Antral pulmonary vein ablation for patients with AF * left atrial fibrosis/electrical scar assessment by electroanatomical mapping * followed by 6 months OAC (3 months blanking period + 3 months observation period) * in case of AF-recurrence in month 4-6: re- pulmonary vein ablation * followed again by 6 months OAC (3 months blanking period + 3 months observation period) AF-free patients as assessed by 72h Holter ECG and symptoms wil be random-izedals to the following two interventional arms: * Experimental arm (group A): OAC with dabigatran for 12 months * Control arm (group B): No OAC (no placebo medication) for 12 months - Cerebral MRI at randomisation and 12 months later

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-09-15
• Completion: 2020-09-15
• First posted: 2014-02-20
• Last updated: 2022-11-07

Locations

19 sites across 1 country: Germany